See full prescribing information for afinitorafinitor disperz. These highlights do not include all the information needed to use. Please see full prescribing information for inlyta. Linear pharmacokinetics were observed in the dose range. Bicitra package insert pdf medscape nephrolithiasis prevention dosing for albrights solution, bicitra sodium medscape prescription drug monographs are based on fdaapproved. Medlineplus information on axitinib a lay language summary of important information about this drug that may include the following. Warning and precautions, special populations and dosage and. Learn about inlyta axitinib tablets indicated for the treatment of advanced rcc after failure of one prior systemic therapy. Although inlyta dose adjustment has not been studied in patients receiving strong cyp3a45 inhibitors, if a strong cyp3a45 inhibitor must be coadministered, a dose decrease of inlyta by approximately half is recommended, as this dose reduction is predicted to adjust the axitinib area under the plasma concentration vs time curve auc to the. This is one of the first examples of a new indication for an existing drug being discovered by screening. This patient information has been approved by the u. Afinitor everolimus tablets, for oral use afinitor disperz everolimus tablets for oral suspension. Aug 14, 2018 axitinib should be taken at evenly spaced intervals, usually once every 12 hours.
Eligible, privately insured patients may save on a qualifying prescription with the savings coupon for. Highlights of prescribing information patients at risk of. Information for the patient inlyta 1 mg filmcoated. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Highlights of prescribing information these highlights do not include all the information needed to use tarceva safely and effectively. Inlyta axitinib side effects, images, uses, dosage. The same dosing reduction by one half is suggested in the package insert as a starting dose for patients with baseline moderate hepatic impairment childpugh class b. Dificid package insert pdf view the savings offer for dificid fidaxomicin.
Axitinib may also be used for purposes not listed in this. Inlyta may cause fertility problems in males and females, which may affect your ability to have a child. Tabulated list of adverse reactions table 1 presents adverse reactions reported in a pooled dataset axitinjb patients who received axitinib in clinical studies for. Discard product if it contains particulate matter, is cloudy, or discolored do not freeze. Inlyta axitinib dosing, indications, interactions, adverse. Prescribing information for axitinib prior to initiation. Inlyta axitinib tablets 2ndline mrcc treatment safety info. Inlyta axitinib tablets 2ndline mrcc treatment safety. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended see warnings and precautions 5. Highlights of prescribing information inlytasafely and. Ambisome package insert pdf name of the medicinal product. Food and drug administration approves pfizers inlyta. Axitinib is an oral tyrosine kinase inhibitor selective for vascular endothelial growth factor vegf receptors 1, 2 and 3 that is used in the therapy of advanced renal cell carcinoma. Talk to your healthcare provider if this is a concern for you.
Identification of the substancemixture and of the companyundertaking product name. Dose increase or reduction is recommended based on individual safety and tolerability. Inlyta axitinib fdaapproved patient labeling pfizer medical. Firstline treatment, in combination with axitinib of patients with advanced. Adjuvant axitinib therapy of renal cell cancer in high risk. In the event that this is not possible, the manufacturer recommends the dose of axitinib be reduced by one half. Food and drug administration fda has approved inlyta axitinib, a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma rcc after failure of one prior systemic therapy. Jun 21, 2019 axitinib package insert pdf inlyta axitinib tablet, film coated.
In the pnet study, 183 patients 1% receiving sutent had grade 3 epistaxis, and no patients had other grade 3 or 4 bleeding events. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Hepatotoxicity has been observed in clinical trials and postmarketing experience. Axitinib package insert pdf inlyta axitinib tablet, film coated. For current full prescribing information, please visit. Axitinib is an inhibitor of the efflux transporter pglycoprotein pgp in vitro. Over the course of treatment, patients who tolerate inlyta for at least two consecutive weeks with no adverse reactions grade 2 according to the common toxicity criteria for adverse events ctcae, are normotensive, and are not receiving antihypertension medication. Tell your healthcare provider about all the medicines you take, including prescription and overthecounter medicines, vitamins, and. Treatment with axitinib should be inesrt at imsert 24 hours prior to scheduled surgery. Based on the short halflife of axitinib, steady state is expected within 2 to 3 days of the initial dose. Axitinib has a higher potency of inhibition in comparison to first generation tyrosine kinase inhibitors or pazopanib which may contribute to its better therapeutic window and decreased incidence of adverse effects. Axitinib therapy is commonly associated with transient elevations in serum aminotransferase that are. There is no specific treatment for axitinib overdose.
Dosing of axitinib at 5 mg twice daily resulted in approximately 1. Axitinib interferes with the growth of some cancer cells. Votrient pazopanib tablets, for oral use initial u. The current safety database for axitinib is too small to detect rare and very rare adverse reactions. Mar 28, 2020 axitinib package insert pdf inlyta axitinib tablet, film coated. Use with caution in patients with severe renal impairment. The incidence and severity of hypertension were proportional to drug dosage. Inlyta axitinib is indicated for the treatment of advanced renal cell carcinoma rcc after failure of one prior systemic therapy. Inlyta 1 mg filmcoated tablets each filmcoated tablet contains 1 mg of axitinib. Jan 30, 2020 the current safety database for axitinib is too small to detect rare and very rare adverse reactions.
Based on the plasma halflife, steady state is expected within 2 to 3 days of dosing. No dosage adjustment is required on the basis of patient age or race see sections 4. Jun 29, 2019 axitinib package insert pdf inlyta axitinib tablet, film coated. Highlights of prescribing information these highlights do not. The drug substance is an aptamer, meaning it is the secondary structure i. Axitinib is usually given after other treatments have failed. It has been shown to significantly inhibit growth of breast cancer in animal. Hepatotoxicity see full prescribing information for complete boxed warning. Azilect package insert pdf easy to read fda package insert, drug facts, dosage and administration, and adverse effects for azilect rasagiline. Axitinib is also being studied in the treatment of other types of cancer. Recommended dose modifications of bavencio for adverse reactions are provided. Pembrolizumab plus axitinib versus sunitinib for advanced. Axitinib is used to treat late stage kidney cancer in patients who have received at least one cancer treatment that did not work well.
See full prescribing information for complete boxed warning. Axitinib should be taken at evenly spaced intervals, usually once every 12 hours. Listing a study does not mean it has been evaluated by the u. Inlyta axitinib tablets fact sheet product description inlyta, a kinase inhibitor, is an oral therapy that selectively inhibits vascular endothelial growth factor vegf receptors 1, 2 and 3, which are receptors that can influence tumour growth. Tell your healthcare provider about all the medicines you take, including prescription and overthecounter medicines, vitamins, and herbal supplements. Read all of this leaflet carefully before you start taking this medicine because it contains important. Before taking inlyta, tell your healthcare provider about all of your medical.
Alecensa alectinib capsules, for oral use initial u. Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively. At steady state, axitinib exhibits approximately linear pharmacokinetics within the 1mg to 20mg dose range. Highlights of prescribing information these highlights do not include all the information needed to use afinitorafinitor disperz safely and effectively. Swallow the tablet whole and do not crush, chew, or break it. Read all of this leaflet carefully before you start taking this medicine because it contains.
Full prescribing information 1 indications and usage inlyta is indicated for the treatment of advanced renal cell carcinoma rccafter failure of one prior systemic therapy. Highlights of prescribing information these highlights do not include all the information needed to use votrient safely and effectively. Abstract background the combination of pembrolizumab and axitinib showed antitumor activity in a phase 1b trial involving patients with previously untreated advanced renalcell carcinoma. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. It is not known if inlyta is safe and effective in children. Axitinib inlyta axitinib inlyta is a chemotherapy regimen for renal cell carcinoma kidney cancer. No dosage adjustments required for mild to moderate impairment. Inlyta is a prescription medicine used to treat advanced kidney cancer advanced renal cell carcinoma or rcc when 1 prior drug treatment regimen for your rcc has not worked. See full prescribing information, including boxed warning. Tabulated list of adverse reactions table 1 presents adverse reactions reported in a pooled dataset axitinjb patients who received axitinib in clinical studies for the treatment of patients with rcc see section 5. It has been shown to significantly inhibit growth of breast cancer in animal models and has shown partial responses in clinical trials with renal cell carcinoma rcc and several other tumour types. Inlyta axitinib fdaapproved patient labeling pfizer.
Axitinib, an inhibitor of vascular endothelial growth factor receptor vegfr, has been an important addition to currently available therapies for advanced rcc. Prescribing information pdf, search, whats new, other resources, therapeutic. In vitro studies in human hepatocytes indicated that axitinib does not induce cyp1a1, cyp1a2, or cyp3a45. Highlights of prescribing information these highlights do not include all the information needed to use alecensa safely and effectively. If you vomit shortly after taking axitinib, do not take another dose. Highlights of prescribing information patients at risk. Argatroban package insert pdf store in original package until time of use. Axitinib is a second generation tyrosine kinase inhibitor with greater selective inhibition of vegf1, vegf2, and vegf3 only.
143 736 1235 1032 1222 1460 651 629 1429 4 1482 1093 807 108 1262 39 754 892 1110 1281 1394 1289 1227 49 167 680 648 444 528 1198 544 511 30 1328 596 342 588 300 1344 634 84 1088